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Corza Medical will operate in 13 countries in North America, Europe and Asia, and have manufacturing sites in the U.S., Mexico, Germany, China and the UK. Read More
The company said its device is the first temperature-controlled, irrigated radiofrequency (RF) ablation system embedded with diamonds approved by the agency. Read More
Complaints involving the possible failure of a device to meet any of its specifications weren’t evaluated and investigated by Medtronic’s Heart Valves Division, according to a Form 483 the firm received following an Oct. 13-26, 2020 inspection of Medtronic’s Santa Ana, California facility. Read More
Numerous repeat observations including failure to establish corrective and protective action (CAPA) and design control procedures were observed during an Oct. 5-7, 2020 FDA inspection of CPAPNEA Medical Supply’s Phoenix, Arizona facility. Read More
Failure to control product that did not conform to specifications, and failure to validate software landed contract manufacturer Viant AS&O Holdings in hot water with the FDA following an Oct. 20-23, 2020 inspection at the firm’s Orchard Park, New York facility. Read More
Mylan and three pharmacy benefit managers — CVS Caremark, Express Scripts and OptumRx — must face a class-action lawsuit claiming that the drugmaker paid bribes and kickbacks to the three companies to ensure a monopoly market for EpiPen, a federal judge has ruled. Read More